Trials / Completed
CompletedNCT02821715
Safety and Efficacy of THN102 on Sleepiness in Narcoleptic Patients
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 51 (actual)
- Sponsor
- Theranexus · Industry
- Sex
- All
- Age
- 18 Years – 65 Years
- Healthy volunteers
- Not accepted
Summary
This Phase 2 study is a 8-site, double-blind, randomised, placebo-controlled, 3-way cross-over trial, involving 3 treatments with Modafinil 300 mg or the combination drug THN102 (Modafinil/Flecainide 300 /3 mg, Modafinil/Flecainide 300 /27 mg).
Detailed description
The 3 double blind periods (2-week) follow a stabilisation period for modafinil at 300 mg/day (open, 2-week) and are followed by a one-week washout period with the same modafinil dose.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Active comparator: Modafinil + placebo | |
| DRUG | THN102 300/3 | |
| DRUG | THN102 300/27 |
Timeline
- Start date
- 2016-09-01
- Primary completion
- 2018-12-01
- Completion
- 2019-02-01
- First posted
- 2016-07-01
- Last updated
- 2020-09-04
- Results posted
- 2020-09-04
Locations
8 sites across 2 countries: Belgium, France
Source: ClinicalTrials.gov record NCT02821715. Inclusion in this directory is not an endorsement.